Recall Number,Trade Name/Product,Recall Class,Date Posted,Recalling Manufacturer,Reason for Recall
Z-2268-2013,PORT-A-CATH and PORT-A-CATH II implantable venous and arterial access systems - Smith Medical; Deltec; REF 21-2386-24; 11 Fr Introducer Set with Peel-Away Sheath; Sterile EO; Rx OnlyPORT-A-CATH and PORT-A-CATH II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications; fluids; and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.,2,Sep-23-2013,Smiths Medical ASD; Inc.,Smiths Medical is conducting a voluntary recall of PORT-A-CATH and PORT-A-CATH II Implantable Venous and ArterialAccess Systems and Introducer Sets.Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets.Smiths Medical has received no reports
Z-2269-2013,PORT-A-CATH and PORT-A-CATH II implantable venous and arterial access systems - Smiths Medical; Deltec:REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System.REF 21-8052-24 & REF 21-8053-24 ; Port-A-Cath II Dual-Lumen; Polysulfone /Titanium Venous Access System.Sterile EO; Rx Only.PORT-A-CATH and PORT-A-CATH II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications; fluids; and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.,2,Sep-23-2013,Smiths Medical ASD; Inc.,Smiths Medical is conducting a voluntary recall of PORT-A-CATH and PORT-A-CATH II Implantable Venous and ArterialAccess Systems and Introducer Sets.Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets.Smiths Medical has received no reports